Guidance And Manufacturer’s Declaration – Electromagnetic Immunity - Fresenius Medical Care 2008T Operator's Manual

Appendix C
Guidance and manufacturer's declaration – electromagnetic immunity
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T hemodialysis machine should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic ±6 kV contact
discharge (ESD) ±8 kV air
(Level 3)
IEC 61000-4-2
Electrical fast ±2 kV for power supply
transient/burst lines
±1 kV for input/output
IEC 61000-4-4 lines
Surge ±1 kV line(s) to line(s)
±2 kV line(s) to earth
IEC 61000-4-5
Voltage Dips, short <5 % U
interruptions, and (>95 % dip in U
voltage variation on for 0.5 cycles
power supply input
lines 40 % U
IEC 61000-4-11 (60 % dip in U
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 seconds
Power-Frequency 3 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
272
Compliance level
±6 kV contact
±8 kV air
(Level 3)
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % U
T T
) (>95 % dip in U
T
for 0.5 cycles
40 % U
T T
) (60 % dip in U
T
for 5 cycles
70 % U
T T
) (30 % dip in U
T
for 25 cycles
<5 % U
T T
) (>95 % dip in U
T
for 5 seconds
3 A/m
2008T Machine Operator's Manual P/N 490122 Rev N
Electromagnetic environment –
guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial and/or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
)
typical commercial or hospital
T
environment. If the user of the 2008T
hemodialysis machine requires
continued operation during power mains
)
interruptions, it is recommended that
T
the 2008T hemodialysis machine be
powered from an uninterruptible power
supply or a battery.
)
T
)
T
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.